Quality Risk Management in the FDA-Regulated Industry, Second Edition - Hardcover

José Rodríguez-Pérez

Hardcover

ISBN 10: 0873899482 ISBN 13: 9780873899482

Publisher: ASQ Quality Press, 2017

Synopsis

The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years.

This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice.

All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.

About this title

About the Author

Dr. José (Pepe) Rodríguez-Pérez is the president of Business Excellence Consulting Inc. (BEC), a Puerto Rico-based, global consultant, training and remediation firm in the areas of regulatory compliance, risk management, and regulatory training in the FDA-regulated sector. He s also president of BEC Spain. He is a biologist and earned his doctoral degree in biology from the University of Granada (Spain). He served as professor and director of the Microbiology Dept. at one of the Puerto Rico schools of medicine. He also served as Technical Services manager at a manufacturing plant of Abbott Laboratories in Puerto Rico. From 2003 to 2012, he was professor for graduate studies of the Polytechnic University of Puerto Rico, and served as a Science Advisor for the FDA from 2009 to 2011. Rodríguez-Pérez is a senior member of ASQ, as well as a member of AAMI, ISPE, PDA, and RAPS. He is an ASQ-certified Six Sigma Black Belt, Quality Manager, Quality Engineer, Quality Auditor, Quality HACCP Auditor, Biomedical Auditor, and Pharmaceutical GMP Professional. He is also the author of the best-selling books Handbook of Investigation and Effective CAPA Systems, Second Edition and The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals, both available from ASQ Quality Press.

Edition details

• Publisher: ASQ Quality Press
• Publication date: 2017
• Language: English
• ISBN 10: 0873899482
• ISBN 13: 9780873899482
• Binding: Hardcover
• Edition number: 2
• Number of pages: 368